{"id":4256,"date":"2021-07-23T01:47:41","date_gmt":"2021-07-22T18:47:41","guid":{"rendered":"https:\/\/gmpgroups.com.vn\/solution\/tu-van-he-thong-quan-ly-chat-luong-gxp-iso\/"},"modified":"2024-04-08T14:50:56","modified_gmt":"2024-04-08T07:50:56","slug":"gxp-iso-standard-consultancy","status":"publish","type":"mona_solution","link":"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/","title":{"rendered":"GxP\/ISO Standard Consultancy"},"content":{"rendered":"

One of the biggest concerns of the pharmaceutical, cosmetic, food and medical devices industries. It’s the quality of your products. The GxP standard is a set of regulations and guidelines to solve this problem systematically and effectively. Join GMP Groups to learn more about the GxP standard in the article below.\u00a0<\/span><\/p>\n

1. What is the GxP & ISO standard?<\/b><\/span><\/h2>\n

The GxP standards were established by the U.S. Food and Drug Administration. The term surrounds many different regulations in many different areas. What is GxP? The letter G stands for “Good” and P stands for “Practice”. ‘X’ in the middle is a variable that can be replaced by any word that completes the acronym appropriately.<\/span><\/p>\n

These regulations and guidelines focus primarily on:<\/span><\/p>\n

– Product traceability<\/span><\/p>\n

– Accountability<\/span><\/p>\n

– Data integrity<\/span><\/p>\n

Although GxP regulations include many different sets of regulations, the most common are GMP, GLP and GSP.<\/span><\/p>\n

GMP (Good Manufacturing Practices)<\/b><\/span><\/h3>\n

GMP is part of a quality management system that ensures factory (infrastructure) controls, human conditions and controls production processes to meet hygiene and safety standards that provide consumers with the elimination of the risk of cross-contamination and confusion.<\/span><\/p>\n

GLP (Good Laboratory Practice)<\/b><\/span><\/h3>\n

GLP is a set of principles and standards on quality management system related to the process of organization and conditions for conducting non-clinical research in pharmaceutical activities for human health and environmental safety that are planned, implemented, monitored, recorded, storage and reporting.<\/span><\/p>\n

GSP (Good Storage Practices)<\/b><\/span><\/h3>\n

GSP is a set of principles and standards relating to appropriate measures for the preservation and transportation of raw materials and products at all stages of production, storage, storage, transportation and distribution of drugs in order to ensure and maintain the best safety and quality of drugs, medicinal materials through adequate control throughout the storage process.<\/span><\/p>\n

ISO (International Organization for Standardization)<\/b><\/span><\/h3>\n

Not only does it stop at meeting the standards of domestic law, but businesses also try to meet international standards including ISO standards.<\/span><\/p>\n

ISO is an international set of standards set by ISO to make everything done in accordance with the standards including providing international standard specifications to ensure products, services and systems, ensuring quality, safety and efficiency.<\/span><\/p>\n

Some of Iso’s common standards such as:<\/span><\/p>\n

–\u00a0 Environmental Management System (ISO 9001:2015)<\/span><\/p>\n

– Quality management system in the field of production and trading of medical instruments and supplies (ISO 13485: 2016)<\/span><\/p>\n

2. Quality management system consulting services at GMP Groups<\/b>\u00a0<\/span><\/span><\/h2>\n

Building a quality management system is not easy. This requires investment in people, equipment and related procedures. Therefore, most businesses need the support and advice of a specialized unit in the field of quality management consultancy.<\/span><\/p>\n

As a company operating for many years in the field of quality management consultancy, GMP Groups has a team of experts who are experienced pharmacists and engineers leading in the quality system of GMP, GSP, GLP & ISO system deployment.<\/span><\/p>\n

GMP GROUPS ensures comprehensive consultation of GMP, GSP, GLP &ISO systems until certification is received including:<\/span><\/p>\n

– GxP Standard Consultancy:<\/b><\/span><\/h3>\n

+ Consulting on completion of production, testing and warehouse technology<\/span><\/p>\n

+ Consulting to complete the overall premises, investment items in accordance with regulations to meet the requirements of customers<\/span><\/p>\n

+ Equipment cataloging for production (GMP), testing (GLP) and warehouse (GSP)<\/span><\/p>\n

+ Supporting the selection of equipment, tools and consumables for the factory<\/span><\/p>\n

– Basic training of GLP\/GSP\/GMP\/ISO standard<\/b><\/span><\/h3>\n

+ Develop a training plan<\/span><\/p>\n

+ General training in GLP\/GSP\/GMP\/ISO<\/span><\/p>\n

+ Training knowledge on system appraisal: Assessment of HVAC system, production environment, domestic water system, RO water, distilled water, pneumatic, storage conditions, equipment appraisal, production process appraisal, hygiene process appraisal<\/span><\/p>\n

– Instructions for drafting dossiers and documents\u00a0<\/b><\/span><\/h3>\n

+ Cataloging of SOP records and documents<\/span><\/p>\n

+ GMP-related SOP system drafting guidelines<\/span><\/p>\n

+ Develop an original appraisal plan<\/span><\/p>\n

+ Instructions for building IQ, OQ, PQ for production equipment, HVAC system, RO water treatment system, distilled water<\/span><\/p>\n

+ Building a water quality handbook<\/span><\/p>\n

+ Guidance on the development of the outline of production environment appraisal<\/span><\/p>\n

+ GLP\/GSP\/ISO-related SOPs guide<\/span><\/p>\n

– Completing the application for evaluation and certification of GxP standards<\/b><\/span><\/h3>\n

+ Complete IQ, OQ, PQ assessments for equipment, HVAC systems, water, pneumatics<\/span><\/p>\n

+ 03 batches of appraisal and guidance on completion of production process appraisal<\/span><\/p>\n

+ Instructions for completing the application for evaluation<\/span><\/p>\n

– Conduct self-inspection and overcome the existence after self-inspection<\/b><\/span><\/p>\n

– Overcoming inappropriate points after the GMP evaluation team<\/b><\/span><\/p>\n

– Together with the investor maintains the system of documents according to GMP for the next evaluation.<\/b><\/span><\/p>\n

All questions related to <\/span>GxP standard consultancy in general and<\/b> for details of quality management systems, please contact GMP Groups<\/span> For direct support from an expert.\u00a0<\/span><\/span><\/p>\n

GMP Groups Joint Stock Company<\/b><\/span><\/p>\n

Headquarters: <\/b>Lot LK20.8, Ecoriver Eco-Investor, Hai Tan Ward, Hai Duong City, Hai Duong Province<\/span><\/span><\/p>\n

Hotline<\/b>: 0945255457<\/span><\/span><\/p>\n

Website<\/b>: gmpgroups.com.vn<\/span><\/span><\/p>\n

Email<\/b>: info@gmpgroups.com.vn<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

The GxP &ISO standard is a set of regulations and guidelines to solve the quality safety of products in a systematic and very effective way. Join GMP Groups to learn more about the GxP &ISO standard in the article below. <\/p>\n","protected":false},"author":1,"featured_media":3878,"comment_status":"open","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"tags":[],"class_list":["post-4256","mona_solution","type-mona_solution","status-publish","has-post-thumbnail","hentry","category_solution-all"],"yoast_head":"\nGxP\/ISO Standard Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GxP\/ISO Standard Consultancy\" \/>\n<meta property=\"og:description\" content=\"The GxP &ISO standard is a set of regulations and guidelines to solve the quality safety of products in a systematic and very effective way. Join GMP Groups to learn more about the GxP &ISO standard in the article below.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/\" \/>\n<meta property=\"og:site_name\" content=\"T\u01b0 v\u1ea5n thi\u1ebft k\u1ebf thi c\u00f4ng ph\u00f2ng s\u1ea1ch \u0111\u1ea1t chu\u1ea9n GMP v\u00e0 ISO | GMP GROUPS\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/gmpgroups\" \/>\n<meta property=\"article:modified_time\" content=\"2024-04-08T07:50:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/anh-bia-tu-van-gxp-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1071\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/\",\"url\":\"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/\",\"name\":\"GxP\/ISO Standard Consultancy\",\"isPartOf\":{\"@id\":\"https:\/\/gmpgroups.com.vn\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/anh-bia-tu-van-gxp-scaled.jpg\",\"datePublished\":\"2021-07-22T18:47:41+00:00\",\"dateModified\":\"2024-04-08T07:50:56+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/#breadcrumb\"},\"inLanguage\":\"en\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en\",\"@id\":\"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/#primaryimage\",\"url\":\"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/anh-bia-tu-van-gxp-scaled.jpg\",\"contentUrl\":\"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/anh-bia-tu-van-gxp-scaled.jpg\",\"width\":2560,\"height\":1071,\"caption\":\"D\u1ecbch v\u1ee5 t\u01b0 v\u1ea5n ti\u00eau chu\u1ea9n GxP v\u00e0 ISO\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/gmpgroups.com.vn\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"GxP\/ISO Standard Consultancy\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/gmpgroups.com.vn\/#website\",\"url\":\"https:\/\/gmpgroups.com.vn\/\",\"name\":\"T\u01b0 v\u1ea5n thi\u1ebft k\u1ebf thi c\u00f4ng ph\u00f2ng s\u1ea1ch \u0111\u1ea1t chu\u1ea9n GMP v\u00e0 ISO | GMP GROUPS\",\"description\":\"V\u1edbi ph\u01b0\u01a1ng ch\u00e2m \u201cT\u1ed1i \u0111a h\u00f3a gi\u00e1 tr\u1ecb v\u00e0 l\u1ee3i \u00edch cho kh\u00e1ch h\u00e0ng\u201d, GMP Groups cam k\u1ebft kh\u00f4ng ng\u1eebng c\u1eadp nh\u1eadt c\u00e1c y\u00eau c\u1ea7u v\u1ec1 GMP\",\"publisher\":{\"@id\":\"https:\/\/gmpgroups.com.vn\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/gmpgroups.com.vn\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/gmpgroups.com.vn\/#organization\",\"name\":\"GMP Groups\",\"url\":\"https:\/\/gmpgroups.com.vn\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en\",\"@id\":\"https:\/\/gmpgroups.com.vn\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/logo-header.png\",\"contentUrl\":\"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/logo-header.png\",\"width\":152,\"height\":50,\"caption\":\"GMP Groups\"},\"image\":{\"@id\":\"https:\/\/gmpgroups.com.vn\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/gmpgroups\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"GxP\/ISO Standard Consultancy","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/","og_locale":"en_US","og_type":"article","og_title":"GxP\/ISO Standard Consultancy","og_description":"The GxP &ISO standard is a set of regulations and guidelines to solve the quality safety of products in a systematic and very effective way. Join GMP Groups to learn more about the GxP &ISO standard in the article below.","og_url":"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/","og_site_name":"T\u01b0 v\u1ea5n thi\u1ebft k\u1ebf thi c\u00f4ng ph\u00f2ng s\u1ea1ch \u0111\u1ea1t chu\u1ea9n GMP v\u00e0 ISO | GMP GROUPS","article_publisher":"https:\/\/www.facebook.com\/gmpgroups","article_modified_time":"2024-04-08T07:50:56+00:00","og_image":[{"width":2560,"height":1071,"url":"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/anh-bia-tu-van-gxp-scaled.jpg","type":"image\/jpeg"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/","url":"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/","name":"GxP\/ISO Standard Consultancy","isPartOf":{"@id":"https:\/\/gmpgroups.com.vn\/#website"},"primaryImageOfPage":{"@id":"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/#primaryimage"},"image":{"@id":"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/#primaryimage"},"thumbnailUrl":"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/anh-bia-tu-van-gxp-scaled.jpg","datePublished":"2021-07-22T18:47:41+00:00","dateModified":"2024-04-08T07:50:56+00:00","breadcrumb":{"@id":"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/#breadcrumb"},"inLanguage":"en","potentialAction":[{"@type":"ReadAction","target":["https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/"]}]},{"@type":"ImageObject","inLanguage":"en","@id":"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/#primaryimage","url":"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/anh-bia-tu-van-gxp-scaled.jpg","contentUrl":"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/anh-bia-tu-van-gxp-scaled.jpg","width":2560,"height":1071,"caption":"D\u1ecbch v\u1ee5 t\u01b0 v\u1ea5n ti\u00eau chu\u1ea9n GxP v\u00e0 ISO"},{"@type":"BreadcrumbList","@id":"https:\/\/gmpgroups.com.vn\/en\/solution\/gxp-iso-standard-consultancy\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/gmpgroups.com.vn\/en\/"},{"@type":"ListItem","position":2,"name":"GxP\/ISO Standard Consultancy"}]},{"@type":"WebSite","@id":"https:\/\/gmpgroups.com.vn\/#website","url":"https:\/\/gmpgroups.com.vn\/","name":"T\u01b0 v\u1ea5n thi\u1ebft k\u1ebf thi c\u00f4ng ph\u00f2ng s\u1ea1ch \u0111\u1ea1t chu\u1ea9n GMP v\u00e0 ISO | GMP GROUPS","description":"V\u1edbi ph\u01b0\u01a1ng ch\u00e2m \u201cT\u1ed1i \u0111a h\u00f3a gi\u00e1 tr\u1ecb v\u00e0 l\u1ee3i \u00edch cho kh\u00e1ch h\u00e0ng\u201d, GMP Groups cam k\u1ebft kh\u00f4ng ng\u1eebng c\u1eadp nh\u1eadt c\u00e1c y\u00eau c\u1ea7u v\u1ec1 GMP","publisher":{"@id":"https:\/\/gmpgroups.com.vn\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/gmpgroups.com.vn\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en"},{"@type":"Organization","@id":"https:\/\/gmpgroups.com.vn\/#organization","name":"GMP Groups","url":"https:\/\/gmpgroups.com.vn\/","logo":{"@type":"ImageObject","inLanguage":"en","@id":"https:\/\/gmpgroups.com.vn\/#\/schema\/logo\/image\/","url":"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/logo-header.png","contentUrl":"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/logo-header.png","width":152,"height":50,"caption":"GMP Groups"},"image":{"@id":"https:\/\/gmpgroups.com.vn\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/gmpgroups"]}]}},"_links":{"self":[{"href":"https:\/\/gmpgroups.com.vn\/en\/wp-json\/wp\/v2\/mona_solution\/4256","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gmpgroups.com.vn\/en\/wp-json\/wp\/v2\/mona_solution"}],"about":[{"href":"https:\/\/gmpgroups.com.vn\/en\/wp-json\/wp\/v2\/types\/mona_solution"}],"author":[{"embeddable":true,"href":"https:\/\/gmpgroups.com.vn\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gmpgroups.com.vn\/en\/wp-json\/wp\/v2\/comments?post=4256"}],"version-history":[{"count":9,"href":"https:\/\/gmpgroups.com.vn\/en\/wp-json\/wp\/v2\/mona_solution\/4256\/revisions"}],"predecessor-version":[{"id":10809,"href":"https:\/\/gmpgroups.com.vn\/en\/wp-json\/wp\/v2\/mona_solution\/4256\/revisions\/10809"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/gmpgroups.com.vn\/en\/wp-json\/wp\/v2\/media\/3878"}],"wp:attachment":[{"href":"https:\/\/gmpgroups.com.vn\/en\/wp-json\/wp\/v2\/media?parent=4256"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/gmpgroups.com.vn\/en\/wp-json\/wp\/v2\/tags?post=4256"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}